Implantable devices including a mesh and a pivotable film

ABSTRACT

The present disclosure relates to implantable medical devices which include at least one mesh and at least one film pivotably attached to the mesh.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority to, and the benefit of, U.S.Provisional Patent Application Ser. No. 61/511,686, filed on Jul. 26,2011, the entire contents of which are hereby incorporated by reference.

BACKGROUND

1. Technical Field

The present disclosure relates generally to implantable medical devices,and more particularly, to implantable medical devices which include atleast one mesh pivotably attached to at least one film, wherein the filmis pivotable between a first position and a second position.

2. Background of Related Art

Surgical meshes may be used during both laparoscopic and open surgeryfor repair of many types of defects and injuries. For example, surgicalmeshes are commonly used in the repair of hernias. The meshes may beused to provide support to surrounding tissue.

During hernia repair, a mesh may be placed over the entirety of damagedtissue and some of the healthy tissue surrounding the defect. The meshcan be held in place by a fixation device that attaches the mesh to thesurrounding tissue. A variety of different fixation devices may be usedto anchor the mesh into the tissue. For example, a needled suture may bepassed through the mesh and the tissue to hold the mesh in a positionwhich spans the injured tissue. In other instances, staples, tacks,clips and pins may also be passed through the mesh and the tissue nearthe defect to anchor the implant in a position which spans the injuredtissue.

Unfortunately, the use of such fixation devices may damage or weaken themesh. In some instances wherein the mesh further includes an additionallayer such as a film, the use of such fixation devices may also damageand/or weaken the film. Since known films are permanently attached to atleast one side of the mesh, passage of the fixation device through themesh and into the tissue, also forces the fixation device through theattached film. Although troubling for any film material, the damageinflicted by the fixation devices upon films designed to preventadhesion may be most troubling, since such damage may createopportunities for the ingrowth of tissue and the formation of unwantedadhesions and scar tissue. In addition, multilayer implants may requirethe surgical personnel to alter the use of certain fixation devices toaccommodate the thickness of such multilayer implants wherein the filmis permanently attached to the mesh.

Although methods that require the use of fixation devices have beenproven effective in anchoring such multilayer implants into the tissue,penetration of the additional layers by such devices may weaken ordamage the overall strength of the implant, as well as the implantsability to deliver therapeutic agents, and/or prevent tissue adhesions.Thus, implantable devices which allow for the mesh to be secured intothe tissue separately from the additional layers is desirable in orderto further limit the amount of trauma to the additional film layers.

SUMMARY

Accordingly, the present disclosure relates to implantable medicaldevices which include a surgical mesh pivotably connected to a polymericfilm. The mesh may generally be a textile or fabric created to promotetissue ingrowth and support injured tissue. The film may generally bepolymeric in nature and may be intended to further enhance the ingrowthof tissue into the implant, prevent adhesions of surrounding tissue,deliver therapeutic agents and/or simply provide addition support to theimplant. In certain embodiments, at least a portion of the film isfixedly attached to the mesh. In certain embodiments, the film may beconnected to the mesh via a pivot member. In other embodiments, theimplantable medical device further includes at least one therapeuticagent. In still other embodiments, the film may be a single layer. Inyet other embodiments, the film may include multiple polymeric layers.

Methods of forming such devices are also disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing objects and advantages of the disclosure will become moreapparent from the reading of the following description in connectionwith the accompanying drawings, in which:

FIGS. 1A and 1B are a perspective view and side view, respectively, ofan implantable medical device a first closed position according to oneembodiment described in the present disclosure;

FIGS. 2A and 2B are a perspective view and side view, respectively, ofan implantable medical device a second open position according to oneembodiment described in the present disclosure;

FIGS. 3A and 3B are a top view and side view, respectively, of animplantable medical device a second open position according to oneembodiment described in the present disclosure;

FIGS. 4A and 4B are a top view and side view, respectively, of animplantable medical device a first closed position according to oneembodiment described in the present disclosure;

FIGS. 5A and 5B are a top view and side view, respectively, of animplantable medical device a second open position according to oneembodiment described in the present disclosure;

FIGS. 6A and 6B are a top view and side view, respectively, of animplantable medical device a second open position according to oneembodiment described in the present disclosure;

FIG. 6C is a side view of the implantable device of FIGS. 6A, 6B, in afirst open position according to one embodiment described in the presentdisclosure;

FIGS. 7A and 7B are a top view and side view, respectively, of animplantable medical device a second open position according to oneembodiment described in the present disclosure;

FIG. 8 is a side view of an implantable medical device according to oneembodiment described in the present disclosure;

FIG. 9 is a diagram showing the weave of three sheets forming a medicaldevice according to one embodiment described in the present disclosure;and

FIG. 10 is a diagrammatic side view of a device permitting the formationof spiked naps on the medical device of FIG. 9 according to anotherembodiment described in the present disclosure.

DETAILED DESCRIPTION

The present disclosure relates to implantable medical devices whichinclude a surgical mesh pivotably connected to a film. By pivotable, thefilm is repositionable between a first position wherein the film coversat least a first side of the mesh and a second position wherein the filmdoes not cover at least a first side of the mesh. In certainembodiments, at least a portion of the film is fixedly attached to themesh. In certain embodiments, the film may be connected to the mesh viaa pivot member. In other embodiments, the implantable medical devicefurther includes at least one therapeutic agent.

By implantable, the medical devices described herein may be positioned,for any duration of time, at a location within a body, such as within aportion of the abdominal cavity. Furthermore, the terms “implantation”and “implanted” refer to the positioning, for any duration of time, of amedical device at a location within a body, such as within a portion ofthe abdominal cavity.

The implantable medical devices described herein include at least onesurgical mesh. The surgical mesh described herein may include porousfabrics made from intertwined filaments. The filaments may extendhorizontally and vertically in a manner which produces sections wherethe filaments cross-over one another creating points of commonintersection. The surgical mesh may be woven, non-woven, knitted orbraided. In some embodiments, the filaments may form two-dimensional orthree-dimensional meshes. Some examples of two-dimensional and/orthree-dimensional mesh substrates may be found in U.S. Pat. No.7,021,086, U.S. Pat. No. 6,596,002, U.S. Pat. No. 7,331,199, the entirecontents of which are incorporated by reference herein.

Suitable meshes for use in the present disclosure include, for example,a collagen composite mesh such as PARIETEX™ Composite Mesh (commerciallyavailable from Tyco Healthcare Group LP, d/b/a Covidien). PARIETEX™Composite Mesh is a 3-dimensional polyester weave with a resorbablecollagen film bonded on one side. Another suitable mesh includesParietex Progrip™ self-fixating mesh (also commercially available fromCovidien). Parietex Progrip™ is a polyester mesh which includes polylactic acid (PLA) grip members. Other suitable meshes include those soldunder the names PARIETENE®, PARIETEX™, SURGIPRO™ (all commerciallyavailable from Covidien); PROLENE™ (commercially available from Ethicon,Inc.); MARLEX®, DULEX®, 3D MAX® mesh, PERFIX® plug, VENTRALEX®, andKUGEL® patch (all commercially available from C.R. Bard, Inc.);PROLITE™, PROLITE ULTRA™ (all commercially available from AtriumMedical); COMPOSIX®, SEPRAMESH®, and VISILEX® (all commerciallyavailable from Davol, Inc.); and DUALMESH®, MYCROMESH®, and INFINIT®mesh (all commercially available from W.L. Gore). Additionally, mesheswithin the scope and context of this disclosure may include biologicmaterials such as allografts (i.e., AlloDerm® Regenerative Tissue Matrixfrom Lifecell), autografts, and xenografts (i.e., PERMACOL™, fromCovidien). In alternate embodiments, processed/purified tissues may alsobe employed.

In certain preferred embodiments, Parietex™ Composite Mesh or Parietex™Pro-grip may be utilized in accordance with the present invention.

The mesh may include filaments such as monofilaments or multi-filamentsand, in embodiments, a plurality of multi-filaments may be combined toform yarns. It is envisioned that the mesh may be configured to any sizeand/or shape suitable for hernia repair. Further, the filaments maycomprise core/sheath constructs.

The medical devices described herein may be formed using any methodwithin the purview of those skilled in the art. Some non-limitingexamples include, weaving, knitting, braiding, crocheting, extruding,spraying, casting, molding, and combinations thereof. In embodiments,the medical device may include a two or three dimensional surgical meshwhich is woven, knitted, braided, or crocheted.

In certain embodiments, the medical device may be a surgical meshknitted on a warp knitting machine, of the tricot or Raschel type, withat least three sheets or warps of yarn and as many guide bars.

In one embodiment, as illustrated in FIG. 9, a rear bar is threaded, oneguide full and one guide empty, with first mono- or multi-filaments 10of a biocompatible polymer as represented as a solid line. Anintermediate bar is threaded, one guide full, three guides empty, withsecond mono- or multi-filaments 11 of a biocompatible polymer asrepresented as a broken line in FIG. 9. The intermediate bar works insuch a way as to obtain a zigzag openwork pattern between the columns ofmeshes. Finally, a front bar is threaded, one guide full, one guideempty, and works in a chain stitch with third mono- or multi-filaments12 a biocompatible polymer as represented by a thin line in FIG. 9. Thethird filament 12, i.e., a chain stitch, imprisons first filament 10 andmaintains the length of the mesh while contributing to the formation ofthe mesh with the intermediate sheet formed by the second filament 11.The different filaments may form yarns and may be worked according tothe following chart:

Warp Rear bar I Intermediate bar II Front bar III Raschel Front bar IIntermediate bar II Rear bar III 7 3 1 7 2 0 — — — 3 4 0 4 5 1 — — — 0 10 0 — — 4 2 3 3 — 1 0 — 4 5

The rear bar places the first filament or yarn in partial weft under thechain stitch and “thrown” onto the needle not forming a chain stitch.For this reason, at the next row, the needle not forming a chain stitchnot being supplied permits escape of the filament which forms a loop 14a projecting from the front face of the mesh.

The threading—one guide full, three guides empty—in the intermediatebar, associated with the displacement, makes it possible to form a lightground texture, stable in width, and open-worked to permit good tissueintegration.

The mesh 14 thus obtained may be provided with loops 14 a (FIG. 10)which may be perpendicular to one of the mesh surfaces. Loops 14 a mayalso include a rigidity and hold at a right angle which may be obtainedby the rigidity or nerve of the filaments employed. This rigidity may benecessary for the subsequent formation of grip members which ensure agrip function to at least a portion of the implantable medical device.

On leaving the loom, mesh 14 may be subjected to a thermosettingoperation which stabilizes the mesh length and width. The mesh may thenbe subjected to a phase of formation of the grip members consisting, asis shown in FIG. 10, in passing the mesh over a cylinder 13 containingan electrical heating resistor. Mesh 14 is pressed flat on cylinder 13by two pairs of rollers, upstream 15 a, 15 b and downstream 16 a, 16 b,respectively, which are vertically displaceable for controlling thispressing force.

This control as well as that of the temperature of the resistor placedin cylinder 13 and of the speed of movement of mesh 14 across cylinder13 make it possible to melt the head of each of loops 14 a so that eachloop 14 a forms two grip members 17.

Each grip member 17 thus may have a substantially rectilinear bodyprotruding perpendicularly with respect to mesh 14 and, at the free endof this body, a head 17 a of greater width than that of the body. Head17 a has a generally spheroidal shape or a mushroom shape. Grip member17 gives mesh 14 the ability to attach to tissue when implanted. Inaddition, grip members 17 may attach to other portions of mesh 14 whenfolded or rolled. The grip members may be positioned along any portionof the mesh and in any quantity and/or configuration. For example, insome embodiments, the grip members may be positioned on the same portionof the mesh as the film. In other embodiments, the grip members may bepositioned on a different portion of the mesh which does not include thefilm.

Any biocompatible material may be used to form the mesh describedherein. For example, the mesh may be made from non-bioabsorbablematerials, such as polypropylene, polyethylene terethphalate,polytetrafluoroethylene, and the like. In other examples, the mesh maybe made from bioabsorbable materials, such as polylactide,polyglycolide, polycaprolactone, polydioxanone, polysaccharides and thelike. In embodiments, the mesh may be made from a combination ofabsorbable and non-bioabsorbable materials.

The medical devices described herein also include a polymeric film layerwhich may be made from a biocompatible material. The biocompatiblematerial may be a homopolymer or a copolymer, including randomcopolymer, block copolymer, or graft copolymer. The biocompatiblematerial may be a linear polymer, a branched polymer, or a dendrimer.The biocompatible material may be of natural or synthetic origin and maybe bioabsorbable or non-bioabsorbable.

Some non-limiting examples of bioabsorbable materials used to form thefilm include polymers selected from the group consisting of aliphaticpolyesters; polyamides; polyamines; polyalkylene oxalates;poly(anhydrides); polyamidoesters; copoly(ether-esters);poly(carbonates) including tyrosine derived carbonates;poly(hydroxyalkanoates) such as poly(hydroxybutyric acid),poly(hydroxyvaleric acid), and poly(hydroxybutyrate); polyimidecarbonates; poly(imino carbonates) such as such as poly(bisphenolA-iminocarbonate and the like); polyorthoesters; polyoxaesters includingthose containing amine groups; polyphosphazenes; poly(propylenefumarates); polyurethanes; polymer drugs such as polydiflunisol,polyaspirin, and protein therapeutics; biologically modified (e.g.,protein, peptide) bioabsorbable polymers; and copolymers, blockcopolymers, homopolymers, blends, and combinations thereof.

More specifically, aliphatic polyesters include, but are not limited to,homopolymers and copolymers of lactide (including lactic acid, D-,L- andmeso lactide); glycolide (including glycolic acid);epsilon-caprolactone, p-dioxanone (1,4-dioxan-2-one); trimethylenecarbonate (1,3-dioxan-2-one); alkyl derivatives of trimethylenecarbonate; Δ-valerolactone; β-butyrolactone; γ-butyrolactone;ε-decalactone; hydroxybutyrate; hydroxyvalerate; 1,4-dioxepan-2-one(including its dimer 1,5,8,12-tetraoxacyclotetradecane-7,14-dione);1,5-dioxepan-2-one; 6,6-dimethyl-1,4-dioxan-2-one; 2,5-diketomorpholine;pivalolactone; α,α diethylpropiolactone; ethylene carbonate; ethyleneoxalate; 3-methyl-1,4-dioxane-2,5-dione;3,3-diethyl-1,4-dioxan-2,5-dione; 6,8-dioxabicycloctane-7-one; andpolymer blends and copolymers thereof.

In certain embodiments, the hydrophobic polymers of the films mayinclude homopolymers or copolymers which include lactide, glycolide,dioxanone, trimethylene carbonate, and ε-caprolactone. For example, thetherapeutic agents described herein may be combined with copolymers,i.e., random, or block copolymers, of lactide and glycolide or glycolideand ε-caprolactone. Increasing the amount of glycolide may increase thefilms degradation rate. While increasing the amount of lactide and/orcaprolactone may extend the degradation/absorption profile of the film.For example, lactide rich copolymers, i.e., greater than about 50%lactide, may be particularly useful to enhance a particular polymer'ssolubility, such as glycolide. Other suitable bioabsorbable materialsmay include but are not limited to poly(amino acids) including proteinssuch as collagen (I, II and III), elastin, fibrin, fibrinogen, silk, andalbumin; peptides including sequences for laminin and fibronectin (RGD);polysaccharides such as hyaluronic acid (HA), dextran, alginate, chitin,chitosan, and cellulose; glycosaminoglycan; mucilage, pectin; andcombinations thereof.

The term “collagen” is meant to include any type of collagen, whethernatural or synthetic, of human or animal origin, such as, for example,enriched human collagen of type I, human collagen of type III, alsoenriched, human collagen of type I+III or of type IV or other collagenssuch as animal collagen of type I or of type I+III. The collagen may beoxidized or non-oxidized.

In certain embodiments, the collagen may be oxidized withoutcrosslinking. For example, native collagen may be dipped in an acidsolution and/or washed, to eliminate the telopeptides, notably by pepsindigestion.

The collagen may also be modified by oxidative cleavage. For thispurpose periodic acid or one of its salts can be used, applying thetechnique described by M. TARDY et al. (FR-A-2 601 371 and U.S. Pat. No.4,931,546, the entire contents of which are hereby incorporated byreference).

It is recalled briefly that this technique consists of mixing thecollagen in acid solution with a solution of periodic acid or one of itssalts at a concentration of between 1 and 10⁻⁵M, preferably between 510⁻³ and 10⁻¹M, at a temperature of between 10 and 25° C. for 10 minutesto 72 hours.

This process breaks down some of the collagen's components, these beinghydroxylysine and the sugars, thus creating reactive sites withoutcausing crosslinking.

The oxidative cleavage of collagen allows moderate cross-linking laterin the collagenic material but does not exclude the possibility ofproviding this function by other means of moderate cross-linking, forexample by beta or gamma irradiation, or other agents of moderatecross-linking, for example chemical reagents at suitably low andnon-toxic doses.

For some applications, the polymer film layers described herein mayinclude collagen which is not oxidized or a mixture in any proportionsof non-oxidized and oxidized collagens.

Additionally, synthetically modified natural polymers such as celluloseand polysaccharide derivatives, including alkyl celluloses, hydroxyalkylcelluloses, cellulose ethers, cellulose esters, nitrocelluloses, andchitosan may be utilized. Examples of suitable cellulose derivativesinclude methyl cellulose, ethyl cellulose, hydroxypropyl cellulose,hydroxypropyl methyl cellulose, hydroxybutyl methyl cellulose, celluloseacetate, cellulose propionate, cellulose acetate butyrate, celluloseacetate phthalate, carboxymethyl cellulose (CMC), cellulose triacetate,and cellulose sulfate sodium salt. These may be collectively referred toherein, in embodiments, as “celluloses.” In certain embodiments, thefilm layer may comprise carboxymethylcellulose.

Both the mesh and/or the film may further consist of at least oneoptional ingredient. Some examples of suitable optional ingredientsinclude emulsifiers, viscosity enhancers, dyes, pigments, fragrances, pHmodifiers, wetting agents, plasticizers, antioxidants, and the like. Theoptional ingredients may represent up to about 10% of the mesh and/orfilm by weight.

In some embodiments, the film may include at least one plasticizer,i.e., glycerol, PEG, etc. For instance, in some embodiments, the filmmay include a combination of carboxymethylcellulose and glycerol. Inother embodiments, the film may include collagen and at least one of PEGand glycerol.

The films described herein may be formed by any suitable method known tothose skilled in the art. In certain embodiments, a solution may beformed which includes the suitable polymeric material and any optionalingredients. The solution may be cast bulk sheet stock, sprayed using anultrasonic sprayer, extruded, molded and the like, to form the filmsdescribed herein.

In certain embodiments, the polymeric film may be formed using anultrasonic spraying nozzle onto an inert substrate. Spraying filmsresults in a unique ability to include a high therapeutic payload of atherapeutic agent. For example, the medical device as described hereinmay be fabricated by passing a first solution containing a hydrophobicpolymer and a second solution containing a therapeutic agent through anultrasonic spray nozzle to form droplets. The droplets may be mixedwhile falling towards or being deposited onto an inert substrate, suchas silicone sheet, or a portion of the mesh to form a film. In someembodiments, prior to spraying the film, an inert substrate may bepositioned on the portion of the mesh which the film is not meant tobecome fixedly attached to. Thus, upon formation of the film, the filmmay adhere to the portions of the mesh which are not covered by theinert substrate and the film will not fixedly attach to the portions ofthe mesh which are covered by the inert substrate.

Alternatively, the film may be cast directly on a portion of the meshsurface, optionally utilizing an inert substrate disposed between thefilm and the mesh. In other embodiments, the film may be formed directlyon a portion of the mesh. In still other embodiments, the film may beformed before being connected to the mesh. In yet another embodiment,the film may be combined with the pivot member before being combinedwith the mesh.

In some embodiments, the films include a single layer containing ahydrophobic polymer and a therapeutic agent. In other embodiments, thefilms include a first layer containing a hydrophobic polymer and asecond layer containing a therapeutic agent. In still other embodiments,the films include a tri-layer structure wherein a second layercontaining a therapeutic agent is positioned between a first layercontaining a hydrophobic polymer and a third layer containing the sameor different hydrophobic polymer.

The hydrophobic polymers used to form the films may initially formpolymer solutions, including suspensions, emulsions, dispersions and thelike, prior to being passed through an ultrasonic sprayer. Somenon-limiting examples of solvents suitable for forming the polymersolutions may include methylene chloride, chloroform,N-methylpyrrolidone, tetrahydrofuran, dimethylformamide, methanol,ethanol, hexanes, acetone and combinations thereof. The polymer mayrepresent from about 1.0% to about 50% (w/w) in the solution.

In some embodiments, the solvent used to form the hydrophobic polymersolution may not be the same solvent used to form the therapeutic agentsolution. In some embodiments, the therapeutic agent is not miscible inthe solvent used to form the polymer solution.

The term “therapeutic agent”, as used herein, is used in its broadestsense and includes any substance or mixture of substances that providesa beneficial, therapeutic, pharmacological, and/or prophylactic effect.The agent may be a drug which provides a pharmacological effect.

The term “drug” is meant to include any agent capable of rendering atherapeutic affect, such as, anti-adhesives, antimicrobials, analgesics,antipyretics, anesthetics (e.g. local and systemic), antiepileptics,antihistamines, anti-inflammatories, cardiovascular drugs, diagnosticagents, sympathomimetics, cholinomimetics, antimuscarinics,antispasmodics, hormones, growth factors, muscle relaxants, adrenergicneuron blockers, antineoplastics, immunogenic agents,immunosuppressants, gastrointestinal drugs, diuretics, steroids, lipids,lipopolysaccharides, polysaccharides, platelet activating drugs,clotting factors, and enzymes. It is also intended that combinations ofagents may be used.

Other therapeutic agents, which may be included as a drug include:anti-fertility agents; parasympathomimetic agents; psychotherapeuticagents; tranquilizers; decongestants; sedative hypnotics; sulfonamides;sympathomimetic agents; vaccines; vitamins; antimalarials; anti-migraineagents; anti-parkinson agents such as L-dopa; anti-spasmodics;anticholinergic agents (e.g., oxybutynin); antitussives;bronchodilators; cardiovascular agents, such as coronary vasodilatorsand nitroglycerin; alkaloids; analgesics; narcotics such as codeine,dihydrocodeinone, meperidine, morphine and the like; non-narcotics, suchas salicylates, aspirin, acetaminophen, d-propoxyphene and the like;opioid receptor antagonists, such as naltrexone and naloxone;anti-cancer agents; anti-convulsants; anti-emetics; antihistamines;anti-inflammatory agents, such as hormonal agents, hydrocortisone,prednisolone, prednisone, non-hormonal agents, allopurinol,indomethacin, phenylbutazone and the like; prostaglandins and cytotoxicdrugs; chemotherapeutics; estrogens; antibacterials; antibiotics;anti-fungals; anti-virals; anticoagulants; anticonvulsants;antidepressants; and immunological agents.

Other examples of suitable agents, which may be included in the filmsdescribed herein include, for example, viruses and cells; peptides,polypeptides and proteins, as well as analogs, muteins, and activefragments thereof; immunoglobulins; antibodies; cytokines (e.g.,lymphokines, monokines, chemokines); blood clotting factors; hemopoieticfactors; interleukins (e.g., IL-1, IL-3, IL-4, IL-6); interferons (e.g.,β-IFN, α-IFN and γ-IFN); erythropoietin; nucleases; tumor necrosisfactor; colony stimulating factors (e.g., GCSF, GM-CSF, MCSF); insulin;anti-tumor agents and tumor suppressors; blood proteins such as fibrin,thrombin, fibrinogen, synthetic thrombin, synthetic fibrin, syntheticfibrinogen; gonadotropins (e.g., FSH, LH, CG, etc.); hormones andhormone analogs (e.g., growth hormone); vaccines (e.g., tumoral,bacterial and viral antigens); somatostatin; antigens; blood coagulationfactors; growth factors (e.g., nerve growth factor, insulin-like growthfactor); bone morphogenic proteins; TGF-B; protein inhibitors; proteinantagonists; protein agonists; nucleic acids such as antisensemolecules, DNA, RNA, and RNAi; oligonucleotides; polynucleotides; andribozymes.

Some specific non-limiting examples of water-soluble drugs that may beused in the present polymeric films include, lidocaine, bupivacaine,tetracaine, procaine, dibucaine, sirolimus, taxol, chlorhexidine,polyhexamethylene, thiamylal sodium, thiopental sodium, ketamine,flurazepam, amobarbital sodium, phenobarbital, bromovalerylurea, chloralhydrate, phenyloin, ethotoin, trimethadione, primidone, ethosuximide,carbamazepine, valproate, acetaminophen, phenacetin, aspirin, sodiumsalicylate, aminopyrine, antipyrine, sulpyrine, mepirizole, tiaramide,perixazole, diclofenac, anfenac, buprenorphine, butorphanol, eptazocine,dimenhydrinate, difenidol, dl-isoprenaline, chlorpromazine,levomepromazine, thioridazine, fluphenazine, thiothixene, flupenthixol,floropipamide, moperone, carpipramine, clocapramine, imipramine,desipramine, maprotiline, chlordiazepoxide, clorazepate, meprobamate,hydroxyzine, saflazine, ethyl aminobenzoate, chlorphenesin carbamate,methocarbamol, acetylcholine, neostigmine, atropine, scopolamine,papaverine, biperiden, trihexyphenidyl, amantadine, piroheptine,profenamine, levodopa, mazaticol, diphenhydramine, carbinoxamine,chlorpheniramine, clemastine, aminophylline, choline, theophylline,caffeine, sodium benzoate, isoproterenol, dopamine, dobutamine,propranolol, alprenolol, bupranolol, timolol, metoprolol, procainamide,quinidine, ajmaline, verapamil, aprindine, hydrochlorothiazide,acetazolamide, isosorbide, ethacrynic acid, captopril, enalapril,delapril, alacepril, hydralazine, hexamethonium, clonidine, bunitrolol,guanethidine, bethanidine, phenylephrine, methoxamine, diltiazem,nicorandil, nicametate, nicotinic-alcohol tartrate, tolazoline,nicardipine, ifenprodil, piperidinocarbamate, cinepazide, thiapride,dimorpholamine, levallorphan, naloxone, hydrocortisone, dexamethasone,prednisolone, norethisterone, clomiphene, tetracycline, methylsalicylate, isothipendyl, crotamiton, salicylic acid, nystatin,econazole, cloconazole, vitamin B₁, cyclothiamine, vitamin B₂, vitaminB₃, vitamin B₅, vitamin B₆, vitamin B₇, vitamin B₉, vitamin B₁₂, vitaminC, nicotinic acid, folic acid, nicotinamide, calcium pantothenate,pantothenol, panthetin, biotin, ascorbic acid, tranexamic acid,ethamsylate, protamine, colchicine, allopurinol, tolazamide, glymidine,glybuzole, metoformin, buformin, orotic acid, azathioprine, lactulose,nitrogen mustard, cyclophophamide, thio-TEPA, nimustine, thioinosine,fluorouracil, tegafur, vinblastine, vincristine, vindesine, mitomycin C,daunorubicin, aclarubicin, procarbazine, cisplatin, methotrexate,benzylpenicillin, amoxicillin, penicillin, oxycillin, methicillin,carbenicillin, ampicillin, cefalexin, cefazolin, erythromycin,kitasamycin, chloramphenicol, thiamphenicol, minocycline, lincomycin,clindamycin, streptomycin, kanamycin, fradiomycin, gentamycin,spectinomycin, neomycin, vanomycin, tetracycline, ciprofloxacin,sulfanilic acid, cycloserine, sulfisomidine, isoniazid, ethambutol,acyclovir, gancyclovir, vidabarine, azidothymidine, dideoxyinosine,dideoxycytosine, morphine, codeine, oxycodone, hydrocodone, cocaine,pethidine, fentanyl, polymeric forms of any of the above drugs and anycombinations thereof.

The water-soluble drug may not need to be converted to a salt form,i.e., tetracycline hydrochloride. In some embodiments, the therapeuticagent may include an anesthetic, i.e., bupivacaine, lidocaine,benzocaine, and the like.

Although the above therapeutic agents have been provided for thepurposes of illustration, it should be understood that the presentdisclosure is not so limited. In particular, although certaintherapeutic agents are specifically referred to above, the presentdisclosure should be understood to include analogues, derivatives andconjugates of such agents.

The therapeutic agent may be combined with any portion of the medicaldevice, including the mesh, the film layer and/or the pivot member. Insome embodiments, the therapeutic agent may be included in the polymericfilm to provide sustained release of the therapeutic agent followingimplantation. Because the film may include a high payload of therapeuticagent, the polymeric films may provide sustained release of the agentfor longer periods of time.

Turning now to FIGS. 1A and 1B, implantable medical device 100 isillustrated including film 110 pivotably attached to mesh 120 and in afirst or closed position wherein a substantial portion of film 110covers at least one side of mesh 120. Although film 110 is not shown incomplete contact with mesh 120, it is envisioned that film 110 has theability to cover mesh 120 completely in the first or closed position.

In FIGS. 2A and 2B, implantable medical device 200 is illustratedincluding film 210 pivotably attached to mesh 220 and in a second oropen position wherein a substantial portion of film 210 is not attachedto mesh 220 and does not cover at least one side of mesh 220. Film 210includes first portion 210 a which is fixedly attached to mesh 220 andsecond portion 210 b which is free of mesh 220. First portion 210 a offilm 210 is fixedly attached to mesh 220 via connector 215. Connector215 may represent any implantable material suitable and/or capable ofsecuring first portion 210 a to mesh 220. Some non-limiting examplesinclude adhesives, sutures, staples, clips, and the like. In someembodiments, the connector may include an adhesive, such as acyanoacrylate. In other embodiments, first portion 210 a of film 210 maybe fixedly attached to mesh 220 through increased pressure and/orenergy, such as heat, to physically bond the two together.

Although film 210 is shown approximately parallel or 180° relative tomesh 220, it is envisioned that film 210 may be repositioned to anyvariety of angles α ranging from 0 to 360 degrees relative to mesh 220.In addition, although shown in a generally planar configuration,implantable medical device 200, including film 210 and/or mesh 220 arenot intended to be limited to planar configurations only and mayrepresent non-planar configurations as well.

As depicted in FIGS. 3A and 3B, device 300 includes film 310 includingaperture 312, mesh 320 including opening 322, and pivot member 330.Pivot member 330 passes through aperture 312 and opening 322 topivotably connect film 310 to mesh 320. The diameter of aperture 312 andopening 322 may be the same or different, however, the diameter of eachmust be sufficient in size to accommodate pivot member 330. Asillustrated in FIGS. 3A and 3B, pivot member 330 may represent aspool-shape wherein top portion 330 a and bottom portion 330 b of pivotmember 330 include extensions 331 to increase the diameter at the topand bottom portions 330 a, 330 b, of pivot member 330 to frictionallyhold film 310 and mesh 320 on pivot member 330.

Pivot member 330, like film 310 and mesh 320, may be made from anybiocompatible material and in embodiments may be made from anybioabsorbable material, non-bioabsorbable, and/or combinations of suchmaterials as previously described herein. It is envisioned that in someembodiments, pivot member 330 may remain as a portion of the implantablemedical device and may be implanted into tissue. In other embodiments,it is envisioned that following implantation, pivot member 330 and/orsome portion of film 310 and/or mesh 320 may simply be detached fromimplantable medical device 300 prior to, during, or after implantation,and removed from the tissue.

In FIGS. 4A and 4B, device 400 includes film 410 including aperture 412,mesh 420 including opening 422, and pivot member 430. Pivot member 430passes through aperture 412 and opening 422 to pivotably connect film410 to mesh 420. The diameter of aperture 412 and opening 422 may be thesame or different, however, the diameter of each must be sufficient insize to accommodate pivot member 430. As illustrated in FIGS. 4A and 4B,pivot member 430 may represent a spool-shape wherein top portion 430 a,bottom portion 430 b, and middle portion 430 c of pivot member 430include extensions 431 to increase the diameter at the top, bottom, andmiddle portions 430 a, 430 b, 430 c of pivot member 430 to frictionallyhold film 410 and mesh 420 on pivot member 430. Middle portion 430 c maybe positioned between film 410 and mesh 420 to maintain separation offilm 410 and mesh 420 in the area near pivot member 430 to enhance theability of film 410 and mesh 420 to pivot.

As further shown in FIGS. 4A and 4B, in some embodiments, film 410 maybe larger in area than mesh 420 thus extending past the outer edges ofmesh 420. This configuration may be useful in hernia repair wherein film410 represents an anti-adhesion barrier film. By extending past theouter perimeter of mesh 420, anti-adhesive film 410 may not only preventadhesion alone the top side of mesh 420, but also along the side edgesof mesh 420, which may prevent adhesions along the mesh perimeter.

Turning now to FIGS. 5A and 5B, device 500 include film 510 pivotablyconnected to mesh 520 via pivot member 530. Pivot member 530 is shown inthis embodiment as an O-ring design which includes first and second ends530 a and 530 b which may be designed to matingly engage to form a latch532. Thus pivot member 530 may be manipulated and/or pinched to separatefirst and second ends 530 a and 530 b of pivot member 530 to open theO-ring thereby allowing film 510 and mesh 520 to be rotated, flipped,removed, etc.

As further shown in FIGS. 5A and 5B, in some embodiments, film 510 maybe smaller in area than mesh 520. For example, film 510 may represent acentral portion or band or mesh 520 and following implantation andsecuring of mesh 520 into tissue via sutures, staples, clips, tacks,adhesives, etc., film 510 may simply be rotated via pivot member 530onto mesh 520 to cover the central portion of mesh 520. It is envisionedthat in some embodiments, film 510 may prevent adhesion along thecentral portion of mesh 520. It is further envisioned that in someembodiments, film 510 may be made from a porous material which furtherpromotes tissue ingrowth thereby further anchoring or securing device500 into the tissue.

In some embodiments, pivot member 630, as depicted in FIGS. 6A and 6B,may pass through film 610 and/or mesh 620 more than one time to furthersecure film 610 to mesh 620. Pivot member 630 represents a spiralbinding that runs at least along a portion of the length of film 610 andmesh 620. The spiral binding 630 strengthens the connection between film610 and mesh 620 without reducing the ability of film 610 from pivoting.As further depicted in FIGS. 6A and 6B, in some embodiments, the shapeof film 610 may differ from the shape of mesh 620. In addition, mesh 620may include a plurality of grip members 640 on at least one side of mesh620. In some embodiments, as illustrated in FIGS. 6A and 6B, mesh 620may include a first portion which may be covered by film 610 and asecond portion which may not be covered by film 610 and/or which mayinclude a plurality of grip members 640. As illustrated in FIG. 6C,device 600 includes grip members 640 disposed on a side of the mesh 620,opposite side of the film 610. In alternate embodiments, grip members640 may be disposed on the same side of the mesh 620 as the film 610.

Although shown previously as generally square and/or rectangular inshape, the devices described herein including the film, the mesh and thepivot member may be of any shape. In FIGS. 7A and 7B, device 700includes a generally circular mesh 720 pivotably connected to agenerally circular film 710 via pivot member 730. Film 710 includes atleast one slit 714 which provides film 710 with the flexibility toaccommodate different contours commonly found in the tissue uponimplantation. In some embodiments, the mesh may also include at leastone slit (not shown). In addition to being pivotable to cover anduncover portions of mesh 720, film 710 may also rotate in a clockwiseand/or counter clockwise direction around pivot member 730. Suchmovement allows slit 714 to be moved as necessary according to thetissue at the site of implantation. In addition, mesh 720 furtherincludes grip members 740 on a side opposite film 710.

The implants described herein may be useful in many endoscopic,laparoscopic, arthroscopic, endoluminal, transluminal, and/or opensurgical procedures. Some examples include hernia repair, repair ofvaginal prolapse, ligament repair, tendon repair, and the like. Althoughthe polymeric films described herein may be made from any biocompatiblematerials, in certain procedures, the film layers may be made fromanti-adhesive materials. For example, when implanting the medicaldevices described herein into tissue near Cooper's ligament, it might beuseful to have the flexibility to wrap around or surround the ligament,or any other sensitive tissue such as the spermatic cord, tendons,intestinal tissue, etc., as shown in FIG. 8. In FIG. 8, implant 800includes mesh 820 pivotably attached to anti-adhesive film 810 whereinfilm 810 has been pivoted away from a first side of mesh 420 and wrappedaround Coopers ligament 850 to prevent adhesion between the surroundingtissue and/or mesh 820 and ligament 850.

It will be understood that various modifications may be made to theembodiments disclosed herein. For example, in embodiments the medicaldevice may rolled prior to being delivered into the body via a cannula,trocar or laparoscopic delivery device. In another example, the medicaldevices described herein may be sterilized and packaged into using anysuitable sterilization process, i.e., gamma radiation, and any suitablemedical device package, i.e., an injectable medical device package. Instill other examples, the implants described herein may include morethan one film, mesh, and/or pivot member. Thus, those skilled in the artwill envision other modifications within the scope and spirit of theclaims.

What is claimed is:
 1. An implantable medical device comprising, a meshhaving at least one opening, a film having at least one aperture, and apivot member positioned between the at least one opening of the mesh andthe at least one aperture of the film, wherein the film is pivotablyattached to the mesh via the pivot member and rotatable around the pivotmember.
 2. The implantable medical device of claim 1 wherein the meshcomprises a bioabsorbable material.
 3. The implantable medical device ofclaim 1 wherein the mesh comprises a non-bioabsorbable material selectedfrom the group consisting of polypropylene, polyethylene terephthalate,expanded polytetrafluoroethylene, condensed polytetrafluoroethylene andcombinations thereof.
 4. The implantable medical device of claim 1wherein the mesh comprises polypropylene.
 5. The implantable medicaldevice of claim 1 wherein the film comprises a bioabsorbable material.6. The implantable medical device of claim 1 wherein the film comprisespolylactide.
 7. The implantable medical device of claim 1 wherein thefilm comprises collagen.
 8. The implantable medical device of claim 1wherein the film comprises an anti-adhesion barrier.
 9. The implantablemedical device of claim 1 wherein the film comprises an area smallerthan the mesh.
 10. The implantable medical device of claim 1 wherein thefilm further comprises at least one therapeutic agent.
 11. Theimplantable medical device of claim 10 wherein the therapeutic agentcomprises bupivacaine.
 12. The implantable medical device of claim 1wherein the mesh further comprises at least grip member on a sideopposite the film.
 13. The implantable medical device of claim 1 whereinthe pivot member comprises a bioabsorbable material.
 14. The implantablemedical device of claim 1 wherein the mesh is generally circular. 15.The implantable medical device of claim 14 wherein the film is generallycircular.
 16. The implantable medical device of claim 1 wherein the filmfurther comprises at least one slit.
 17. An implantable medical devicecomprising, a planar mesh, an anti-adhesion barrier film pivotablyattached to one side of the planar mesh via a pivot member, the filmincluding two slits, and, a plurality of grip members positioned onanother side of the mesh opposite the film, wherein the anti-adhesionbarrier film is rotatable around the pivot member.
 18. The implantablemedical device of claim 17 wherein the mesh comprises anon-bioabsorbable material.
 19. The implantable medical device of claim17 wherein the film comprises collagen.
 20. The implantable medicaldevice of claim 17 wherein the film comprises an area smaller than themesh.
 21. The implantable medical device of claim 17 wherein the pivotmember comprises a bioabsorbable material.